COORDINATING CENTER FOR CALERIE (COMPREHENSIVE ASSESSMENT OF LONG-TERM EFFECTS
OF REDUCING INTAKE OF ENERGY) STUDIES
RELEASE DATE: May 8, 2002
RFA: AG-02-007
National Institute on Aging
(http://www.nih.gov/nia/)
LETTER OF INTENT RECEIPT DATE: June 12, 2002
APPLICATION RECEIPT DATE: July 12, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The National Institute on Aging (NIA) invites applications for a Cooperative
Agreement (UO1) to establish a Coordinating Center (CC) for the CALERIE
(Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy)
studies. The three recently funded CALERIE sites (also UO1 studies) are
exploratory controlled studies on the effects of sustained caloric
restriction interventions on physiology, body composition, and risk factors
for age-related pathologies in non-obese persons. Each of the three CALERIE
sites will be conducting site-specific protocols, but standardized protocols
will be followed for a Common Data Set of measures conducted at all the
sites. The CALERIE CC will have responsibility for implementing and
participating in processes for making and implementing CALERIE-wide
decisions, participation in development of procedures related the Common Data
Set, management and reporting of data, and participation in data analyses.
The CC will interact with the CALERIE study sites, the CALERIE Steering
Committee, the NIA Program Administrator, and the CALERIE Data and Safety
Monitoring Board (DSMB). The period of support for the CALERIE CC will be
seven years. Up to $700,000 in total (direct plus facilities and
administrative (F&A) costs) costs) for the first year may be requested, with
increments above this level of up to 4% per year for future years.
RESEARCH OBJECTIVES
Background
The three funded CALERIE sites were selected from the responses to the RFA
"Exploratory Studies of Sustained Caloric Restriction in Non-Obese Persons:
Physiologic Effects and Comparisons/ Interactions with Physical Activity, that
was issued by the National Institute on Aging (NIA) in October 13, 2000 (NIH
Guide to Grants and Contracts
(http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-01-001.html).
Detailed information on the background and rationale for these studies may be
found at the above address. Briefly, the CALERIE projects are funded under the
Cooperative Agreement mechanism (UO1) and involve exploratory controlled human
intervention studies on the effects of caloric restriction (CR) interventions
on physiology, body composition, and risk factors for age-related pathologies in
non-obese persons. The primary goals of the CALERIE projects are: to gain
knowledge about the effects in humans of sustained caloric restriction (CR) on
physiology, metabolism, body composition, risk factors for age-related
pathologies, progression of age-related changes, and potential adverse effects,
and to gain knowledge of similarities, differences and interactions between the
effects of CR and physical activity (PA) on the above outcomes when employed
in interventions to prevent weight gain. The endpoints of the CALERIE studies
include energy intake and expenditure, physical activity, body composition,
endocrine responses, insulin sensitivity/glucose metabolism, cardiovascular
function, bone density, immune function, quality of life and potential
adverse effects of CR. Study populations in the CALERIE studies will be
nonobese, with a likely age range of 25-60 years. The expected duration of
the CALERIE projects is seven years. They will be conducted in three phases
as follows:
Phase 1: Protocol Refinement (up to 2 years). Phase I is primarily devoted to
the development of recruitment strategies, determining feasibility and safety
of the proposed CR interventions, as well as standardization of common
measures and methodologies. Approximately 190 subjects are expected to be
studied in Phase 1.
Phase 2: Protocol Implementation (at least two years). Activities under this
phase include the conduct of intervention activities, continued screening and
recruitment of subjects (if necessary), and preliminary data analysis.
Approximately 300 subjects (100 per site) are expected to be studied in Phase
2.
Phase 3: Data analysis and reporting (approximately one year). Each of the
three CALERIE sites will be conducting site-specific protocols, in addition
to standardized protocols that will collect common measures across the sites
(Common Data Set). It is expected that information in the Common Data Set
will be used in studies involving comparisons among sites, and/or studies
that require aggregation of data from multiple sites.
The other organizational components of the CALERIE studies with which the CC
will interact are: the study sites, the Steering Committee, which is the main
decision-making body, subcommittees that report to the Steering Committee,
the Data and Safety Monitoring Board (DSMB), which will oversee progress of
the studies and monitor the safety of human subjects, and, the NIA Program
Administrator for the CALERIE projects. The Principal Investigator (PI) of
the CALERIE CC will participate as a voting member of the Steering Committee.
This RFA is to establish a Coordinating Center (CC) for the CALERIE studies
to provide coordination, and organizational and analytical support. Overall
the activities requested for the CC consist of organizational, informational,
and data management and analysis functions for activities of the CALERIE
Steering Committee, subcommittees, and DSMB.
Specifically, the CC will work in collaboration with the CALERIE study sites
and NIA program staff to:
1. Coordinate with the CALERIE Steering Committee the selection of the
common data collection protocols, and standardized forms, and the data
entry system for the creation and maintenance the Common Data Set for
measurements to be done in common by two or all three of the CALERIE
sites. Prepare, disseminate, and update the CALERIE Common Data Set
Manual of Procedures (MOP), data collection forms, databases, and
results reporting summaries for the CALERIE sites, and maintain and
verify for correctness the resulting Common Data Set.
2. Provide or arrange for training to all CALERIE site personnel as needed
on data management and analysis, and quality control and quality
assurance.
3. Collaborate with the CALERIE study sites (conditional on approval by
the Steering Committee and NIA Program Administrator) in the analysis
of common data both for internal use by the study sites and for
publications.
4. Provide the NIA Program Administrator, the DSMB, and the Steering
Committee with reports based on statistical and other analyses of
issues related to the Common Data Set, or other needs arising during
the course of studies.
5. Coordinate the logistics for the establishment and operation of a
common laboratory for doubly labeled water analyses, and participate
with the study sites in the development of data quality control
procedures, and information databases regarding these samples and
analyses over the course of the CALERIE studies.
6. Coordinate logistics for the establishment, operation, and quality
control of laboratory assays for the Common Data Set, and a repository
for biological specimens from the CALERIE study sites, including
development of procedures for monitoring samples to be sent, assuring
assay quality, data quality control, procedures for transfer of
specimens to the repository, and related databases.
7. Prepare detailed reports in standardized formats on progress of study-
specific recruitment, protocol completion, compliance, and adverse
events, for use by the Steering Committee, DSMB, and NIA Program
Administrator.
8. Prepare a list of all CALERIE site-specific data items including the
equipment, test batteries, and assessment techniques that are used.
9. Monitor adherence of CALERIE components to NIH and NIA policies on
transmission of information on adverse events, and maintain a database
on adverse events and responses to them.
10. Support the activities of the CALERIE sites, the CALERIE Steering
Committee, and the CALERIE DSMB through provision of materials,
documentation support, meeting planning and logistics, and conference
call coordination. This includes attendance at Steering Committee,
subcommittee, and DSMB meetings to perform the functions listed above.
11. Participate in all CALERIE Steering Committee and DSMB meetings
and conference calls, and CALERIE Subcommittee conference calls as
needed.
12. Prepare and distribute the minutes and action items from the
CALERIE Steering Committee (SC) and DSMB meetings and conference calls,
CALERIE Site visits, and CALERIE Subcommittee meetings, and provide
timelines for the completion of actions items and updates on the status
of action items as required.
13. Assist the NIA Program Administrator in written, telephone, and
electronic communications with the study sites and with various
committees as requested.
14. Establish databases that catalogue and disseminate information
about all CALERIE publications.
15. Develop and maintain a public and private (secured, password-
protected) CALERIE Web page.
The three funded CALERIE sites and the NIA Program Administrator are
preparing Manuals of Procedures and developing the Common Data Set. By the
anticipated September 30, 2002 start date for the CC, some decisions
regarding the Common Data Set and other CALERIE activities will have been
made, and some protocols begun. However, it is anticipated that many issues
and procedures regarding the Common Data Set and other aspects of CALERIE
Phase 1 studies will still need to be addressed at that time, and will
benefit from CC participation. The decision process for finalizing CALERIE
Phase 2 study protocols will not begin until 2003 at the earliest.
MECHANISM OF SUPPORT
This RFA will use the NIH cooperative agreement (U01) award mechanism. As
an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award
date is September 30, 2002.
The NIH U01 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award." The total project period for an application submitted in response to
the present RFA may not exceed seven years.
FUNDS AVAILABLE
For the initial year of funding the amount of funds requested for the CALERIE
CC should not exceed $700,000 total cost (direct cost + F&A costs).
Requested funding for increments above this level not to exceed 4% per year
for future years is permissible. The size of the proposed budget for each
year should be appropriate for the Phase being conducted by the trials in
that year. No more than one award will be made as a result of this RFA and
funding of this award is contingent upon availability of funds.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
1. Minimal requirements for potential applicants for the CALERIE Coordinating
Center are as follows:
o The applicant must have demonstrated prior experience as a coordinating
center in multicenter studies. Previous experience with dietary or physical
activity interventions, obesity and/or metabolic studies is mandatory.
o The Principal Investigator, with other staff, must have appropriate
biostatistical, data management and coordination expertise.
o The applicant must have the ability to assist in designing protocols and
the data collection system, including transmission via the Internet.
o The applicant must demonstrate the willingness and ability to cooperate
with the CALERIE sites and NIA staff in all design, data collection and
analysis functions. The applicant should provide a plan for developing a
cooperative relationship among the CALERIE sites and between the various
CALERIE organizational components.
o The applicant must have an established data system for collection and
statistical analysis of common data.
2. Collaboration of Coordinating Center with CALERIE Organizational
Components
o The CC will be involved in collaborations with the NIA and the CALERIE
study sites during all phases of the studies. Thus, the applicant is expected
to demonstrate experience in working cooperatively with clinical sites and
sponsoring organizations in a multi-site trial and in overseeing the
implementation of and adherence to a common protocol, as well as assuring
quality control of the data collected. In addition to organizing and
attending regular meetings, the CC will be expected to maintain close
communications with the NIA Program Administrator and the Principal
Investigators of the CALERIE study sites.
o Steering Committee. The primary governing body of the study will be the
Steering Committee, which will have responsibility for overall study design
and policy decisions (described in more detail under Terms and Conditions).
The Principal Investigator of the CC will be a voting member of the Steering
Committee.
o Data and Safety Monitoring Committee (DSMB). An independent committee
will be
established by NIA staff and approved by the Director, NIA, to review the
progress of the study on a regular basis (described in more detail under
Terms and Conditions).
o NIA Program Administrator. The NIA Program administrator function will
be to assist the components as appropriate in all aspects of the CALERIE
studies (described in more detail under Terms and Conditions).
3. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92 and other HHS, PHS, and NIH Grant
Administration policy statements.
The administrative and funding instrument used for this program is a
cooperative agreement (UO1), an assistance mechanism (rather than an
acquisition mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardees is anticipated during performance
of the activity. Under the cooperative agreement, the NIH purpose is to
support and/or stimulate the recipient"s activity by working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility or a dominant role in the activity. Consistent with this
concept, the dominant role and prime responsibility for the activity resides
with the awardees for the project as a whole, although specific tasks and
activities in carrying out the collaborative aspects will be shared among the
awardees and the designated NIA Program administrator.
1. Awardee Responsibilities
The Coordinating Center awardee agrees to work cooperatively with the CALERIE
study sites and will have the primary responsibility for developing and
implementing systems necessary for communications between the various CALERIE
organizational components. The Coordinating Center will facilitate the design
and refinement of all protocols, manuals of operation, and forms. Awardees at
the study sites shall retain custody of, and primary rights to, the site-
specific data developed under their award, subject to Government rights of
access consistent with current HHS, PHS, and NIH policies. The Steering
Committee will define the rules regarding access to and publication of
findings from analysis of common data.
2. Staff Responsibilities
The designated NIA Program Administrator will have substantial
scientific/programmatic involvement during conduct of this activity, through
technical assistance, advice and coordination above and beyond normal program
stewardship of grants. The awardee agrees to accept assistance from the
designated NIA Program Administrator, as described
below:
o Participate in the monitoring of issues relating to recruitment,
treatment, follow-up, quality control, and adherence to protocols.
o Assist in the development and/or adjustment of study protocols.
o In conjunction with the Steering Committee, approve the transition of
study sites from Phase 2 to Phase 3. After approval from the Monitoring
Board, the NIA must accept (approval by the Director, NIA) the protocol
before it can be implemented. The NIA reserves the right to terminate or
curtail the study (or an individual award) in the event
of substantial shortfall in participant recruitment, follow-up, data
reporting, quality control, or other major breech of the protocol, if human
subject safety or ethical issues dictate a premature termination, or if there
is failure to develop or implement mutually agreeable collaborative
protocols.
o Assistance in data analyses
3. Collaborative Responsibilities
The Steering Committee (SC), comprised of each of the Principal Investigators
of the CALERIE study sites, the Principal Investigator of the Coordinating
Center, and the NIA Program Administrator, will have primary responsibility
for developing and finalizing standard definitions/laboratory measures common
to the protocols of the study sites. Each member of the Steering Committee
will have one vote, and all major scientific decisions will be determined by
majority vote of the Steering Committee. A Chairperson for the SC has been
chosen from among the Principal Investigators of the CALERIE study sites.
Subcommittees appointed by the Steering Committee and comprised of the
Principal Investigators and appropriate staff from the study sites, the
Coordinating Center will be involved in design of the protocol and the manual
of operations, and in ongoing functions of the CALERIE studies such as
consideration of potential ancillary studies and preparation of publications.
The SC will meet every three to six months, or as dictated by the needs of
the CALERIE studies.
The DSMB will advise the study sites by periodically reviewing their research
progress and the safety of the study subjects, as well as resolve any serious
conflicts over how the overall study should proceed. The DSMB will be
comprised of experts in relevant medical, statistical and bioethical fields.
The DSMB"s approval will be required before initiation of Phase 1 study
protocols, and before transition to Phase 2. The Chairperson of the Steering
Committee and the NIA Program Administrator will participate as non-voting
members of this Board.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of the U01 award), between U01 awardees and the NIA may be brought
to arbitration. An arbitration panel will be composed of three members: one
selected by the Steering Committee (without NIH representatives voting) or by
the individual U01 awardee in the event of an individual disagreement, a
second member selected by the NIA, and, the third member selected by the two
prior selected members. For U01 awardees, this special arbitration procedure
will in no way affect the awardee"s right to appeal an adverse action in
accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS
regulations at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues
Direct inquiries regarding programmatic issues to:
Charles Hollingsworth, Dr. P.H.
Branch Chief, Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E-327 MSC 9205
Bethesda, MD 20892-9205
Express Mail Zip Code: 20814
Telephone: 301/435-3047, FAX: 301/402-1784
E-mail: hollinc@nia.nih.gov
Direct inquiries regarding peer review issues to:
Mary Nekola, Ph.D.
Chief, Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, Maryland 20892-9205
Express Mail Zip Code: 20814
Telephone: 301/496-9666, FAX: 301/402-0066
E-mail: nekolam@nia.nih.gov
Direct inquiries regarding financial or grants management matters to:
Cynthia Riddick
Grants Management Specialist
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N-212
Bethesda, Maryland 20892-9205
Express Mail Zip Code: 20814
Telephone: 301/496-1472, FAX: 301/402-3672
E-mail: riddickc@nia.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Chief of Review
Chief, Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, Maryland 20892-9205
Telephone: 301/496-9666
FAX: 301/402-0066
E-mail: nekolam@nia.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
Supplemental Instructions:
Applicants for the Coordinating Center should address the potential
requirements of the CALERIE studies by providing a description of projected
tasks likely to be performed by the CC and the centralized facilities,
consistent with resources projected to be available for the CALERIE studies.
Plans for collection and handling of data and samples consistent with the
projected needs of the study sites should be discussed. Plans for ensuring
data integrity and quality control should be discussed.
Personnel: The application for CC must describe the expertise of key
scientific, technical and administrative personnel and include a mechanism
for replacing key professional or technical personnel should the need arise.
The Principal Investigator of the Coordinating Center should be a
biostatistician or other professional with experience in directing a
coordinating center for large-scale collaborative multi-site clinical studies
or other large-scale epidemiological research project involving multiple
institutions. Staff needs may be modified as the CALERIE studies progress,
however, adequate support staff should be designated to manage routine tasks:
o PI of the Coordinating Center should provide overall scientific and
biostatistical guidance.
o Project Manager to attend to day-to-day details and communicate necessary
information to study sites and/or to the other CALERIE organizational
components. Staff
training is also a responsibility of the Project Manager.
o Statisticians to help in data analysis.
o System analysts to help with developing and managing the database
programs.
o Computer programmers to develop computer database.
o Clerks and administrative assistants to help in administrative work
and data entry.
Budget: The budgets for the Coordinating Center application should be based
on the applicant"s best judgment of activities likely to be involved during
the different Phases of the CALERIE studies. The Coordinating Center also
will be responsible for organizing meetings of the Data and Safety Monitoring
Board (DSMB) at least twice a year and for supporting the travel of these
individuals to meeting sites and their lodging. These costs should be
included in the budget.
The Phase 1 budget (Year 1) should include costs of establishing the
Coordinating Center staff, as required to carry out the Coordinating Center"s
functions (including costs of training personnel of CALERIE sites for
management and analyses, and quality control and quality assurance of common
data). Phase 1 also will involve development of the protocols and manuals of
operations by the study sites, in conjunction with the Steering Committee for
the CALERIE studies and creation of a database for the common measures
between the study sites. Budgets should include costs of organizing at least
three "in person" Steering Committee meetings and for attendance of necessary
Coordinating Center staff to these meetings.
During Phase 2, the budgets should include projected data handling costs,
reporting functions, meetings and other communications costs, and the
projected expense of performing any interim analyses that may be requested by
the DSMB. The applicant also should address the potential requirements of the
CALERIE studies by budgeting for tasks to be performed for the development of
a repository to store patient samples. It should, however, be understood
that the specific centralized facilities required and their final budgets
will be determined following the design of the final study protocols and the
writing of the manual of operations by the study sites and the Steering
Committee. Budgets should also include costs of organizing three Steering
Committee meetings per year and providing for attendance of necessary Data
Coordinating Center staff.
The Phase 3 budget should be concerned with study closeout, analysis of study
data, and reporting of results in collaboration with the study sites.
Budgets should include the costs of organizing three meetings of the Steering
Committee and providing for attendance
of necessary Coordinating Center staff.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Chief of Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD 20892-9205
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the (NIA). Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration. Applications
should be complete at the time of submission. The Scientific Review Office
(SRO), NIA, will determine whether late materials will be accepted. If late
materials are accepted, they will be limited to three typed pages and the
Scientific Review Administrator (SRA) in charge of the review must authorize
submission.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIA in accordance with the review criteria stated below. As
part of the initial merit review, all applications:
o Will receive a written critique
o May undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Will receive a second level review by the National Advisory Council on
Aging
REVIEW CRITERIA.
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to
judge the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
The final design of the protocols (site-specific and common) will be
developed collaboratively by the CALERIE study sites and the Steering
Committee. In assessing applications for the Coordinating Center, the
scientific review group will focus on whether the applicant recognizes the
significance of the issues involved and has the knowledge necessary to
contribute meaningfully to the final design, including understanding of the
scientific, ethical, and practical issues underlying the CALERIE studies.
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
Does the proposed approach in managing the logistical and data coordination
have scientific and technical merit? Are the proposed plans and experience
relating to data collection, management, editing, processing, analysis, and
reporting adequate? Are the plans for coordination with the study site
investigators adequate? Is the approach to developing a cooperative
relationship among the study sites and between the various CALERIE
organizational components adequate? Are the plans for exercising appropriate
leadership in matters of study design, data acquisition, data management, and
data analysis demonstrated?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
Does the applicant for the Coordinating Center offer innovative ideas on how
to achieve the goals of the CALERIE studies with regard to its design and
administration? Does the proposal address problems that may arise during
the study and provide innovative solutions to such problems?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
Does the application provide evidence of specific competence and relevant
experience of professional, technical, and administrative staff pertinent to
the operation of a Coordinating Center for multi-site studies? Prior
experience collecting data and patient specimens from multiple clinical
sites, monitoring the data quality, and developing and utilizing statistical
methods for analysis of data should be demonstrated. Is there evidence of
experience in and willingness to participate appropriately in a collaborative
study as described in this RFA? Are there adequate assurances that the
Coordinating Center personnel have experience in utilizing procedures that
insure the safety and confidentiality of medical records?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
Has the application documented the adequacy of the proposed facility,
technical hardware, and space for the Coordinating Center? Is there an
appropriate organizational and administrative structure to the proposed
Coordinating Center? Evidence of institutional support and commitment for
the proposed program should be provided.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The CALERIE Coordinating Center will be setting up a
repository of samples from human subjects. Therefore, the Center must comply
with current human subjects protection policies regarding potential patient
identifier information that are associated with these stored samples.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 12, 2002
Application Receipt Date: July 12, 2002
Peer Review Date: September 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 30, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.866, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and to discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.